External Catheter with Antiseptic Agent

ABSTRACT

An external catheter device is disclosed which prevents infection arising from bacterial and/or yeast growth within the external catheter. To achieve such result, the external catheter device is coated with an antiseptic agent that is able to effectively kill and prevent the growth of bacteria and yeast. Additionally, the external catheter device may have an adhesive agent coating on its inner surface to prevent the condom from shifting while on the patient&#39;s penis.

This application is a continuation of U.S. patent application Ser. No.11/526,052, filed Sep. 25, 2006, now U.S. Pat. No. 8,491,552, thecontent of which is hereby incorporated by reference herein in itsentirety into this disclosure.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to catheters. More particularly,the present invention relates to external catheters having antisepticagents capable of killing and/or preventing the growth of bacteriaand/or yeast.

2. Background of the Invention

In home and hospital settings, it is common practice to employcatheterization devices to drain urine from patients. Suchcatheterization devices include indwelling catheters, intermittentcatheters, and external catheters, which are also known as condomcatheters.

In patients with normal control over bladder functions, an externalcatheter is sometimes used instead of an indwelling or intermittentcatheter since the risk of infection or other disease may be minimizedwith an external catheter. An external catheter is not inserted into thepatient's urethra, and it therefore may have some advantages over othercurrent catheterization devices that require temporary or prolongedurethral insertion in order to drain the urine from the bladder.

An external catheter is placed over a patient's penis like a condom usedfor sexual intercourse and has at its end a reservoir connected to atube which is connected to a collection bag. Earlier external catheterswere not self-adhesive and a band around the catheter was used to holdthe catheters in place on the penis. Later advancements were made in theadhesive techniques which resulted in lining the inside of the catheterwith a glue-like substance. This caused the condom-like catheter tostick to the flaccid penis and keep it in place throughout the day. Somealso use a skin-prep pad that is wiped on the penis before the externalcatheter is applied which quickly turns into a sticky gel-like substancewhich further causes the catheter to stick to the penis. This pad is sosticky when first applied that it is difficult to remove withoutdamaging the skin.

An external catheter is usually used on patients who have an ability tocontrol their bladder functions but may have limited hand dexterity orability to get to a toilet, or may be unable to direct their urine flowinto a urinal. Also, an external catheter can be used on individualshaving abnormal bladder function but who may still experiencespontaneous bladder contraction after their bladder is full. This oftenoccurs in patients with stroke, multiple sclerosis, spinal cord injury,traumatic brain injury, etc. An external catheter is not normally usedfor patients with bladders that are unable to contract, such as patientswith spina bifida. External catheters have been mostly comprised of alatex material until recently when silicon catheters have becomepopular.

There are studies that have shown that the rate of urinary tract andbladder infection is lower for individuals who change their externalcondom catheter daily as compared to every other day. Therefore, mostdoctors recommend that an external catheter be changed every day toprevent infections. However, infections do still occur at a significantrate in those individuals who depend on external catheters due to theprolonged presence of residual urine within the tip of the externalcatheter.

Thus, there is a need in the healthcare industry for a catheterizationdevice, specifically an external catheter, that functions effectivelyfor a sustained period of time without being prone to infection.

SUMMARY OF THE INVENTION

The current techniques and devices for catheterization are inefficientand expose the patient to infection. In current external catheterizationdevices, residual urine collects in the reservoir of the catheter. Suchresidual urine can be associated with an increase in bacterial and/oryeast infection and may arise from the proliferation of skin bacteriaand/or yeast within this urine medium. This collection of bacteriaand/or yeast within the external catheter likely results in urinarytract and bladder infections by migration of these organisms retrogradethrough the urethra and into the bladder. These infections may stillarise even if the external catheter is changed daily. In order toprevent this bacterial and/or yeast proliferation, the present inventionproposes an antiseptic coating in at least the reservoir tip of theexternal catheter and an antiseptic coating in conjunction with anadhesive compound coating on the body of the external catheter thatmakes contact with at least the shaft of the penis.

In one exemplary embodiment, the present invention is an externalcatheterization device. The device includes an ensheathing condom;wherein the ensheathing condom contains an antiseptic agent on itsinterior surface.

In another exemplary embodiment, the present invention is an externalcatheterization device. The device includes an ensheathing condom havinga body, an end surrounding the head of the penis, and a reservoir tip;wherein the ensheathing condom has on its inner surface an antisepticagent.

In yet another exemplary embodiment, the present invention is anexternal catheterization device. The device includes an ensheathingcondom having a body which extends over a shaft of a penis, an endsurrounding a head of the penis, and a reservoir tip; a tube connectingend; and a tube connection port; wherein the body, the end, and thereservoir have on their inner surfaces an antiseptic agent coating; andwherein the tube connection port is used to empty urine from within thereservoir and the ensheathing condom.

In another exemplary embodiment, the present invention is an externalcatheterization device. The device includes an ensheathing condom havinga body which extends over a shaft of the penis, an end surrounding ahead of the penis, and a reservoir tip; a tube connecting end; and atube connection port; wherein the body, the end, and the reservoir haveon their inner surfaces an antiseptic agent coating formed from a groupof agents selected from the following: nitrofurazone, chlorhexadine,silver sulfadiazine, minocycline, rifampin, nystatin, fluconazole,miconazole, troconazole, ibutoconazole, or any combination thereof;wherein the tube connection port is used to empty urine from within thereservoir and the ensheathing condom.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of a conventional external catheter without anantiseptic coating according to current catheterization techniques anddevices.

FIG. 1B shows a side view of a conventional external catheter without anantiseptic coating when residual urine collects within the catheter andwhen bacteria and/or yeast proliferate and travel up the patient'surethra.

FIG. 2 shows a side view of an external catheter with an antisepticcoating and an adhesive compound coating on the inside body of thecatheter that makes contact with at least the shaft of the penis whilean antiseptic coating is used on at least the inside of the reservoirtip according to an exemplary embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides for catheterization techniques anddevices which prevent bacterial and/or yeast proliferation within thecatheterization devices thereby preventing infection. In particularembodiments and examples presented herein, such catheters are describedwith respect to urinary catheterization but it must be noted that suchantiseptic and adhesive compound coatings according to the presentinvention are not limited to urinary catheters alone but may beapplicable to any catheterization device that could benefit from the useof such coatings.

A conventional external catheter 110 is shown in FIG. 1A. The externalcatheter 110 includes a reservoir tip 111 with a tube connecting end 112and tube connection port 113. The external catheter 110 is condom-shapedand fits over the shaft 100 and head 101 of the patient's penis. Theexternal catheter 110 is conventionally composed of latex, rubber,silicon, or polyurethane. The external catheter 110 is tight fittingalong the shaft 100 and on the head sides 104 of the penis in order toprevent leakage of urine (not shown) from the head tip 103 down theshaft 100 of the penis. In order to achieve this tight-fit, an adhesiveglue-like material is conventionally used, such as an acrylic resin. Thereservoir tip 111 is loosely fitting over the head tip 103 of the penisin order to allow for urine to collect and pass through the tubeconnecting end 112 and into a connecting tube (not shown).

During urination, urine 130 is collected within the reservoir tip 111and allowed to pass through the tube connecting end 112 as shown in FIG.1B. The accumulated urine 130 may travel down the shaft 100 of the penisas the reservoir tip 111 is expanded due to the pressure exerted by theaccumulated urine 130 on the inside of the external catheter 110. Thiscauses the external catheter to expand out from the penis head 101 asshown in FIG. 1B. As a result of this urine collection in the reservoirtip 111 and along the shaft 100 of the penis, not all of the accumulatedurine 130 may drain out through the tube connecting end 112 and into thetube connection port 113. Thus, some residual urine may remain on theshaft 100, the head sides 101, and the head tip 103 after it is emptiedout into a connecting tube (not shown) and into a collection bag (notshown). Such an accumulation of residual urine around these areas mayresult in the proliferation of bacteria or yeast 120. These bacteria oryeast 120 may originate from the normal epithelial cells on the penisand they may proliferate in the nutritive residual urine. Also, bacteriaor yeast 120 may proliferate during the expected accumulation process ofurine 130 within the external catheter 110 depending on how often theexternal catheter 110 is changed. Once the bacteria or yeast 120 aregiven a nutritive environment to proliferate (e.g., the urine 130), thebacteria or yeast may thereafter travel up the urethra 102 in thedirection of arrows 140. Thus, the bacteria or yeast 120 can lead to atroublesome infection of the patient's bladder (not shown) and urethra102.

An exemplary embodiment of the present invention is external catheter210 as shown in FIG. 2. External catheter 210 may include a reservoirtip 211, a tube connecting end 212, and a tube connection port 213 whichmay all be coated with an antiseptic agent 271 to prevent bacterial oryeast proliferation (not shown). External catheter 210 may also includean adhesive and antiseptic agent combination 270 coating the innersurface of the external catheter 210 at the shaft 200 in order to keepthe external catheter 210 in place. The coating may also coat the innersurface of the external catheter at head sides 204 and just up to thehead tip 203 as shown in FIG. 2. In this way, the external catheter 210may be securely and tightly fitted to the shaft 200 and the head 201 ofthe penis in order to minimize any leakage of urine to these areaswithin the external catheter 210. As such, the adhesive and antisepticagent combination 270 may cover the shaft 200 and the head 201 of thepenis as shown in FIG. 2, or the adhesive and antiseptic combination 270may not cover any portion of the head 201, and it may only cover theshaft 200 of the penis in order to avoid irritating the head 201 of thepenis. In the latter case, the antiseptic agent 271 may coat both theinner surface of the reservoir tip 211 and the inner surface of theexternal catheter surrounding the head 201 of the penis by itselfwithout any adhesive compound. Thus, the adhesive and antisepticcombination 270 may coat only the inner surface of the cathetersurrounding the shaft 200 of the penis up until the base 205 of the head201, and the antiseptic agent 271 may by itself coat the inner surfaceof the catheter surrounding the head 201 of the penis, the reservoir tip211, and tube connecting end 212 and tube connection port 213 in orderto minimize potential irritation to the head 201 of the penis. Both ofthe aforementioned variations involving the adhesive compound (e.g.,whether or not it is on the head 101 of the penis) are within the scopeof this invention so long as the external catheter 210 is able to remainsecurely fitted to the penis.

The antiseptic agent 271 may be composed of any anti-bacterial compoundthat effectively prevents the growth of bacteria (e.g., bacteriostatic)or yeast (e.g. anti-yeast) and/or kills bacteria (e.g., bacteriocidal)or yeast once they are formed. The antiseptic agent 271 shouldpreferably be safe, non-irritating, and hypoallergenic such that it doesnot cause any adverse reactions to the skin of the patient. An exemplaryanti-bacterial agent that may be used in the antiseptic agent for thepresent invention may be nitrofurazone, chlorhexadine, silversulfadiazine, minocycline, rifampin, or any combination thereof. Anexemplary anti-yeast agent that may be used in the antiseptic agent forthe present invention may include, but not be limited to nystatin,fluconazole, miconazole, troconazole, ibutoconazole, or any combinationthereof. These compounds have been effectively and safely used in Foleycatheters (e.g., indwelling catheters) to prevent bacterial or yeastinfection. Thus, a coating comprised of said compounds for the presentinvention may provide a safe and effective prevention of bacterialand/or yeast growth and subsequent infection. Alternatively, theantiseptic agent 271 may be pre-manufactured within the polymeric bodyof the catheter 210. Thus, the polymeric body of the catheter 210 itselfwould have antiseptic properties without the need to add a separateantiseptic agent at a later point after manufacture.

The adhesive material used for this invention may be composed of anycompound that when applied to the inner surface of the catheter, maybind with the epithelial cells of the penis such that the catheterremains stable and secure on the shaft and head of the penis. Theadhesive compound may also be non-irritating such that it may be removedfrom the penis without causing any irritation. The adhesive compound maybe strong enough to resist any sliding movement of the catheter on thepenis, but should preferably not be so strong so as to cause pain duringremoval of the catheter. An exemplary adhesive compound may be anacrylic resin as used in conventional catheters, but any other adhesivecompound that would satisfy the above mentioned limitations would besuitable for use in the present invention as well.

The external catheter 210 may be composed of a material such that it mayresist tearing during application, removal, and while the externalcatheter is fitted tightly around the penis. Also, the materialcomposing the external catheter 210 may bind sufficiently to theadhesive and antiseptic agent combination 270, and the antiseptic agent271 by itself such that said combination or agent by itself can stablyreside on the inner surface of the external catheter while not slidingoff the inner surface of the catheter or sliding down the cathetertowards or away from the shaft 200 of the penis. In this way, thecombination or agent by itself may remain on the inner surface of theexternal catheter 210 at specified areas including but not limited tothe reservoir tip 211, head sides 204, and shaft 200 of the penis. Sucha material for use in the external catheter 210 may include, but is notlimited to, silicon, rubber, latex, polyurethane, or any combinationthereof.

The manufacturing methods that can be employed for the present inventioninclude, but are not limited to, conventional techniques used in theindustry to produce similar function products, as known by a personhaving ordinary skill in the art.

The foregoing disclosure of the exemplary embodiments of the presentinvention has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Many variations andmodifications of the embodiments described herein will be apparent toone of ordinary skill in the art in light of the above disclosure. Thescope of the invention is to be defined only by the claims appendedhereto, and by their equivalents.

Further, in describing representative embodiments of the presentinvention, the specification may have presented the method and/orprocess of the present invention as a particular sequence of steps.However, to the extent that the method or process does not rely on theparticular order of steps set forth herein, the method or process shouldnot be limited to the particular sequence of steps described. As one ofordinary skill in the art would appreciate, other sequences of steps maybe possible. Therefore, the particular order of the steps set forth inthe specification should not be construed as limitations on the claims.In addition, the claims directed to the method and/or process of thepresent invention should not be limited to the performance of theirsteps in the order written, and one skilled in the art can readilyappreciate that the sequences may be varied and still remain within thespirit and scope of the present invention.

What is claimed is:
 1. An external catheterization device, the devicecomprising: an ensheathing condom; wherein the ensheathing condomcontains an antiseptic agent on its interior surface.
 2. The device ofclaim 1, wherein the antiseptic agent contains an anti-bacterial and/oranti-yeast compound.
 3. The device of claim 2, wherein theanti-bacterial compound is composed of nitrofurazone, chlorhexadine,silver sulfadiazine, minocycline, rifampin, or any combination thereof.4. The device of claim 2, wherein the anti-yeast compound is composed ofnystatin, fluconazole, miconazole, troconazole, ibutoconazole, or anycombination thereof.
 5. The device of claim 1, wherein the ensheathingcondom fits tightly around the shaft and head of the penis.
 6. Thedevice of claim 1, wherein the ensheathing condom is further comprisedof an end surrounding a head of the penis and a reservoir tip for urinecollection.
 7. The device of claim 1, wherein the ensheathing condomfurther includes an adhesive compound on its inner surface to keep theensheathing condom in place.
 8. The device of claim 1, further includinga connection port for directing urine out of the ensheathing condom. 9.An external catheterization device, the device comprising: anensheathing condom having a body, an end surrounding the head of thepenis, and a reservoir tip; wherein the ensheathing condom has on itsinner surface an antiseptic agent.
 10. The device of claim 9, whereinthe antiseptic agent is composed of an anti-bacterial and/or anti-yeastcompound.
 11. The device of claim 10, wherein the anti-bacterialcompound is composed of nitrofurazone, chlorhexadine, silversulfadiazine, minocycline, rifampin, or any combination thereof.
 12. Thedevice of claim 10, wherein the anti-yeast compound is composed ofnystatin, fluconazole, miconazole, troconazole, ibutoconazole, or anycombination thereof
 13. The device of claim 9, further including anadhesive agent on the inner surfaces of the body and the end.
 14. Thedevice of claim 9, further including an adhesive agent on the innersurface of the body only.
 15. The device of claim 9, further including aconnection port for directing urine out of the ensheathing condom. 16.An external catheterization device, the device comprising: anensheathing condom having a body which extends over a shaft of a penis,an end surrounding a head of the penis, and a reservoir tip; a tubeconnecting end; and a tube connection port; wherein the body, the end,and the reservoir have on their inner surfaces an antiseptic agentcoating; and wherein the tube connection port is used to empty urinefrom within the reservoir and the ensheathing condom.
 17. The device ofclaim 16, wherein the antiseptic agent coating is composed ofanti-bacterial and/or anti-yeast compound.
 18. The device of claim 16,wherein the anti-bacterial compound is composed of nitrofurazone,chlorhexadine, silver sulfadiazine, minocycline, rifampin, or anycombination thereof.
 19. The device of claim 16, wherein the anti-yeastcompound is composed of nystatin, fluconazole, miconazole, troconazole,ibutoconazole, or any combination thereof.
 20. The device of claim 16,further including an adhesive agent on the inner surfaces of the bodyand the end.